Hydrochloride Sustained-release Tablets Research Articles

PET/CT study of dopamine transporter (DAT) binding with the triple reuptake inhibitor toludesvenlafaxine in rats and humans.

Toludesvenlafaxine is a recently developed antidepressant that belongs to the triple reuptake inhibitor class. Despite the in vitro evidence that toludesvenlafaxine inhibits the reuptake of serotonin (5-HT), norepinephrine (NE) and dopamine (DA), there is no in vivo evidence that toludesvenlafaxine binds to DAT and increases DA level, a mechanism thought to contribute to its favorable clinical performance. Positron emission tomography/computed tomography (PET/CT) was used to examine the DAT binding capacity in healthy rats and human subjects and microdialysis was used to examine the striatal DA level in rats. [18F]FECNT and [11C]CFT were used as PET/CT radioactive tracer for rat and human studies, respectively. In rats, 9mg/kg of toludesvenlafaxine hydrochloride (i.v.) followed by an infusion of 3mg/kg via minipump led to the binding rate to striatum DAT at 3.7 - 32.41% and to hypothalamus DAT at 5.91 - 17.52% during the 45min scanning period. 32mg/kg oral administration with toludesvenlafaxine hydrochloride significantly increased the striatal DA level with the AUC0 - 180min increased by 63.9%. In healthy volunteers, 160mg daily toludesvenlafaxine hydrochloride sustained-release tablets for 4 days led to an average occupancy rates of DAT at 8.04% ± 7.75% and 8.09% ± 7.00%, respectively, in basal ganglion 6h and 10h postdose. These results represent the first to confirm the binding of toludesvenlafaxine to DAT in both rats and humans using PET/CT, and its elevation of brain DA level, which may help understand the unique pharmacological and functional effects of triple reuptake inhibitors such as toludesvenlafaxine. NCT05905120. Registered 14 June 2023. (retrospectively registered).

Method Validation and Monitoring of N-nitrosodimethylamine in Metformin Hydrochloride Products in China by GC-MS/MS

Background: N-nitrosodimethylamine (NDMA) are a sort of genotoxic impurities (GTIs) having strong carcinogenic effects and obvious hepatotoxicity. To monitor the NDMA content of metformin hydrochloride sustained-release tablets and enteric capsules in China from 2018 to 2022, a GC-MS/MS method was established and validated. Materials and Methods: The chromatographic column was Agilent VF-WAXms capillary column (30 m×0.25 mm, 0.25 μm). The GC-MS/MS method was equipped with multiple reaction monitoring (MRM) modes. To assess the quantity of NDMA, the molecular ion at mass-tocharge (m/z) of 74-44 was monitored under the 6 V collision energy, and to assess the quality of NDMA monitoring, the molecular ions at m/z 74-42 were determined. A total of 143 batches of metformin hydrochloride-finished products from 35 enterprises were determined by this method Results: The linear range of the method was 0.25 ~ 50.00 ng/mL, r = 0.9998, S/N > 10, and the limit of detection and quantitation were 0.06 ng/mL and 0.21 ng/mL, respectively. The average recovery was 98.62%, and the RSD was 4.31%. All batches of enteric capsules met the requirements; 38.21% of the 123 batches sustained-release tablets still exceeded the acceptable daily intake. Conclusion: The presented method is sensitive, accurate, precise, and available for both enteric capsules and sustained-release tablets of metformin hydrochloride, which can provide a reference for their quality control. The over-limit phenomenon of NDMA in metformin hydrochloride products poses new challenges and requirements for both the State Drug Administration and enterprises.

Enteral Nutrition Intervention Enhances Analgesic Effect of Morphine Hydrochloride Sustained Release Tablets in Alleviating Cancer Pain

We have explored the effects of enteral nutrition interventions on the analgesic effect of morphine hydrochloride sustained-release tablets in cancer pain therapy. Patients in the control group were monitored in real time, and analgesics were given as needed to improve the pain. Patients in the treatment group received both morphine hydrochloride sustained-release tablets and enteral nutrition interventions. After treatment, the Visual Analogue Scale score, unified Parkinson’s disease rating scale, and Pittsburgh sleep quality index scores in the treatment group were reduced relative to the control group, and Parkinson’s disease sleep scale scores and nutritional indexes were elevated. Levels of interferon-γ and interleukin-2 in the treatment group were elevated relative to the control group, while the levels of interleukin-4 were reduced. The incidence of adverse reactions in the treatment group was 15.79% (21/133), which was lower relative to the control group (31.58%, 42/133). Levels of 5-hydroxytryptamine and brain-derived neurotrophic factor in the treatment group were elevated relative to the control group, while the levels of dopamine declined. To sum up, morphine hydrochloride sustained-release tablets combined with enteral nutrition interventions can decrease the inflammatory response of patients and promote sleep quality

Preparation and Evaluation of Polymer Fused Metformin Hydrochloride Sustained Release Tablet

Preparation and Evaluation of Polymer Fused Metformin Hydrochloride Sustained Release Tablet

The clinical effect of feedforward control nursing combined with methylphenidate sustained-release tablets on children with attention deficit hyperactivity disorder

BackgroundAttention Deficit Hyperactivity Disorder (ADHD) is a common psychological disorder in childhood, also known as child hyperactivity disorder. Its clinical manifestations mainly include excessive activity, inattention, impulsivity, irritability, etc. If the intervention is not carried out in time, it may lead to serious psychological, behavioral, social, learning, or other issues in children, affecting their normal social life. Although drug treatment can improve the symptoms of some ADHD patients, drug treatment alone may cause persistent residual symptoms, addiction and adverse reactions. Feedforward control nursing is an active intervention mode. It realizes the control purpose by controlling variables, plays the role of preventing problems before they occur and solving problems as early as possible. It can provide efficient and high-quality nursing for children. Therefore, our hospital conducted clinical treatment for children with attention deficit hyperactivity disorders through feedforward control nursing combined with methylphenidate sustained-release tablets, in order to provide reference value for the treatment intervention of children with attention deficit hyperactivity disorder.Subjects and Methods120 children with ADHD who were admitted to a psychiatric hospital in the same period were selected as the study subjects. The patients were randomly divided into the experimental group and the control group. The experimental group was given a treatment scheme of feedforward control nursing combined with methylphenidate sustained-release tablets, and the control group was given conventional drug treatment. Before the intervention, both groups were given methylphenidate hydrochloride sustained-release tablets for oral treatment. The initial dose of treatment was 19 mg per day, the maximum dose was 53 mg per day, and the intervention time was 3 months. The children were evaluated once a month with Abbreviated Symptom Questionnaire (ASQ). The lower the score, the better the intervention effect. The experimental data were analyzed by SPSS20.0 software.ResultsAfter 3-month intervention, the ASQ scores of the two groups were compared. The results were shown in Table 1. After the intervention, the scores of the experimental group at 1 month, 2 months and 3 months after the intervention were significantly lower than those before the intervention (P < 0.05), and the scores of the control group at 2 months and 3 months after the intervention were significantly lower than those before the intervention (P < 0.05). The scores of the two groups were compared. The scores of the two groups before the intervention were not statistically significant, but the scores of the experimental group at 1 month, 2 months and 3 months after the treatment were significantly lower than those of the control group (P < 0.05). Among them, * represents P < 0.05 compared with that before intervention, and # represents P < 0.05 compared between groups.Figure 1.Comparison of conners scale scores between the two groups before and after experimental groupConclusionsDrug treatment alone can no longer meet the needs of patients, and the collaborative treatment of multiple therapies has become the current trend and research focus of this disease. In this study, feedforward control nursing combined with methylphenidate sustained-release tablets has a significant intervention effect on children with ADHD, which can improve the children’s sustained attention, effectively improve their behavioral ability and attention, and further improve the satisfaction of the children’s family members with nursing. It is worthy of promotion and application.

Effects of oxycodone hydrochloride sustained-release tablets and morphine hydrochloride sustained-release tablets on peripheral blood T cell levels in advanced lung squamous cell carcinoma with moderate to severe cancer pain.

To investigate the effects of morphine hydrochloride sustained-release tablets and oxycodone hydrochloride sustained-release tablets on T-cell levels in advanced lung squamous cell carcinoma(LUSC) with moderate to severe cancer pain. A retrospective study was used, ninety-eight patients who were admitted to The First Affiliated Hospital of Hebei North University for treatment of advanced LUSC with moderate to severe cancer pain between January 2021 and December 2021 were randomized into two groups(n=49 each) using the sealed envelope system. The reference group was treated with morphine hydrochloride sustained-release tablets, while the experimental group received oxycodone hydrochloride sustained-release tablets to compare pain relief rates(PRRs), levels of T cells, pain intensity, et al. Blood samples were collected for lymphocyte levels by flow cytometry. The experimental group had significantly higher level than the reference group(P<0.05). Before administration, the two groups did not differ greatly in levels of T-cell subsets or pain scores on the visual analog scale(P>0.05, respectively). At 15 days of administration, the Treg level in the experimental group was higher than in the reference group; T helper 17 and 22 cells were reduced in both groups, and the decrease was more pronounced in the experimental group. At seven and 15 days of administration, the experimental group had a VAS score significantly lower than the reference group(P<0.05). The total adverse reaction rate was significantly lower in the experimental group as compared with the reference group(P<0.05). Oxycodone hydrochloride sustained-release tablets demonstrate desirable efficacy and safety in advanced LUSC with moderate to severe cancer pain by modulating T-cells in the body and improving the PRR.

Formulation and Optimization of Propranolol Bilayer Tablets: A Potential Approach for Effective Management of Hypertension

The purpose of this investigation is to formulate and evaluate the antihypertensive drug propranolol hydrochloride sustained-release bilayer tablets. In this formulation, one layer provides a loading dose through the immediate release of the drug and the other layer provides a maintenance dose for up to 12 h through controlled release. Different quantities of polymers such as Kyron T-314, Hydroxypropyl methylcellulose- K4M, and ethyl cellulose were used to make bi-layer tablets by direct compression. The compatibility study of pharmaceutical excipients was conducted through Fourier transform infrared spectroscopy studies and no interaction was found. The pre-compression parameter for the angle of repose, bulk density, tapped density and compressibility index was assessed on the produced granules and the findings were good. The tablets were evaluated for the post-compression parameters for thickness, hardness, friability and in vitro release studies. In vitro dissolution study was approved out for 12 h using United States Pharmacopeia dissolution apparatus I using phosphate buffer of pH 1.2 and 6.8 as dissolution medium. Hydroxypropyl methylcellulose- K4M and ethylcellulose were used in combination in all formulations but optimized formulation propranolol hydrochloride tablet 4 showed a higher rate of drug release up to 12 h as compared to the other formulation and optimized formulations propranolol hydrochloride tablet 4 follows the Higuchi model with non-fickian diffusion based on regression coefficient of the kinetics data of cumulative drug release from the dosage form.

Dissolution profile prediction of sinomenine hydrochloride sustained release tablets, part II: a multisource data fusion approach

Multi-source data fusion methods were utilized to developed dissolution prediction models of sinomenine hydrochloride sustained-release tablets.

Prediction of dissolution profiles of sinomenine hydrochloride sustained-release tablets part I: using near-infrared spectra as predictors

Rapid and accurate methods were developed to predict the dissolution profiles of sustained-release tablets using near-infrared spectroscopy combined with chemometrics.

Formulation and Evaluation of Metformin Hydrochloride Sustained Release Tablet

Metformin hydrochloride (MET) is an oral hypoglycemic agent which improves glucose tolerance in patients with type 2 diabetes and diminishes basal plasma levels of glucose. The aim of this study was to develop and optimize MET matrix tablets for SR application. The SR matrix tablet of MET was prepared by wet granulation technique using Polyvinyl pyrrolidone K30 and hydroxyl propyl methylcellulose of different viscosity grades (HPMC K4M, HPMC K15M, and HPMC K100M). The influence of varying the polymer ratios was evaluated. The excipients used in this study did not modify physicochemical properties of the drug. MET has relatively short plasma half-life, low absolute bioavailability. The need for the administration 2 to 3 times a day when larger doses are required can decrease patient fulfillment. SR formulation that would maintain plasma level for 8-12 h might be sufficient for daily dosing of MET. SR products are needed for MET to prolong its duration of action and to improve patient compliances. The development of oral sustained release systems has been a challenge to formulation scientists due to their inability to restrain and localize the system at targeted areas of the gastrointestinal tract. From all the formulation trial batches, formulation F3 shows the best results. It has been observed that HPMC K100M alone cannot give satisfactory drug release profile but the blend of HPMC K100M and Polyvinyl pyrrolidone K30 together give the best drug release kinetics. Thus, sustained release matrix tablets of metformin hydrochloride can be expected to reduce the frequency of administration and decrease the dose dependent side effects. Keywords: Metformin hydrochloride, SR matrix tablet, HPMC K100M, Wet granulation technique

N-Nitrosodimethylamine formation in metformin hydrochloride sustained-release tablets: Effects of metformin and hypromellose used in drug product formulation

In recent years, nitrosamines have been discovered in some types of drug products that becomes a current regulatory hotspot, and have attracted a lot attention from both regulatory authorities and industry. This manuscript provided an industry perspective on the nitrosamines research. A liquid chromatography coupled with tandem mass spectrometry（LC-MS/MS）method was developed and applied for the quantification of N-nitrosodimethylamine (NDMA) in metformin hydrochloride sustained-release tablets (MET). The key factors resulting in the NDMA formation in MET were identified through forced degradation and drug-excipient studies, which included high temperature, dimethylamine, strong alkali and oxidation conditions, peroxide and alkaline components contained in the formulation as well as the nitrite and nitrate impurities that might be presented in certain excipients. Further, API particle size and water content of the drug product would also affect the growth rate of NDMA. Therefore, the following mitigation strategies to reduce the risk of nitrosamines in the finished drug product are proposed in this manuscript: 1) avoid the use of excipients containing nitrite, nitrate and peroxide impurities; 2) avoid high temperature and strong alkaline environment in the production and storage condition; 3) maintain an appropriate water content level in the formulation. Based on the above principles, it was recommended to add antioxidant or incorporate excipient such as Na2CO3 to modify the formulation pH to weak basic environment in the formulation of MET, which can could effectively prevent formation of NDMA in the stability process.

Comparison of lidocaine and ropivacaine stellate ganglion blockade in treating upper limb postherpetic neuralgia.

To provide a basis for treating postherpetic neuralgia (PHN), we compared the efficacy of lidocaine and ropivacaine stellate ganglion block (SGB) in PHN treatment in the upper limbs.Data from 252 patients with upper-limb PHN were retrospectively analyzed. The lidocaine group (n = 118) was treated with oral pregabalin capsules 75 mg twice a day, tramadol hydrochloride sustained release tablets 100 mg twice a day, and amitriptyline 25 mg once at night combined with ultrasound-guided lidocaine SGB; the ropivacaine group (n = 134) was orally administered the same medicines combined with ultrasound-guided ropivacaine SGB. The visual analog scale (VAS), self-rating anxiety scale (SAS), and adverse reactions were compared between the groups before treatment and at 1 week, 1 month, and 3 months after treatment.There were no significant differences between the lidocaine and ropivacaine groups in terms of sex, age, height, weight, and pain duration (P > .05). There was no significant difference between the groups in VAS and SAS scores before treatment (P > .05). At 1 week, 1 month, and 3 months after ultrasound-guided SGB treatment, the VAS and SAS scores were significantly lower in the ropivacaine group than in the lidocaine group (P < .05). There were no significant differences between the groups in terms of adverse reactions (P > .05).For ultrasound-guided SGB treatment of upper limb PHN, ropivacaine is superior to lidocaine. Ultrasound-guided ropivacaine SGB is safe and effective for the treatment of upper limb PHN.

Can metformin relieve tibiofemoral cartilage volume loss and knee symptoms in overweight knee osteoarthritis patients? Study protocol for a randomized, double-blind, and placebo-controlled trial

BackgroundOsteoarthritis (OA) is the most common joint disease, and is most frequently seen in the knees. However, there is no effective therapy to relieve the progression of knee OA. Metformin is a safe, well-tolerated oral medication that is extensively used as first-line therapy for type 2 diabetes. Previous observational studies and basic researches suggested that metformin may have protective effects on knee OA, which needs to be verified by clinical trials. This study, therefore, aims to examine the effects of metformin versus placebo on knee cartilage volume loss and knee symptoms in overweight knee OA patients by a randomized controlled trial over 24 months.MethodsThis protocol describes a multicenter, randomized, double-blind, and placebo-controlled clinical trial aiming to recruit 262 overweight knee OA patients. Participants will be randomly allocated to the two arms of the study, receiving metformin hydrochloride sustained-release tablets or identical inert placebo for 24 months (start from 0.5 g/day for the first 2 weeks, and increase to 1 g/day for the second 2 weeks, and further increase to 2 g/day for the remaining period if tolerated). Primary outcomes will be changes in tibiofemoral cartilage volume and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score over 24 months. Secondary outcomes will be changes in visual analogue scale (VAS) knee pain, tibiofemoral cartilage defects, effusion-synovitis volume, and tibiofemoral bone marrow lesions maximum size over 24 months. The primary analyses will be intention-to-treat analyses of primary and secondary outcomes. Per-protocol analyses will be performed as the secondary analyses.DiscussionIf metformin is proved to slow knee cartilage volume loss and to relieve knee symptoms among overweight knee OA patients, it will have the potential to become a disease modifying drug for knee OA. Metformin is a convenient intervention with low cost, and its potential effects on slowing down the structural progression and relieving the symptoms of knee OA would effectively reduce the disease burden worldwide.Trial registrationClinicalTrials. gov NCT05034029. Registered on 30 Sept 2021.

Dissolution profiles prediction of sinomenine hydrochloride sustained-release tablets using Raman mapping technique

The work aims to explore the feasibility of Raman mapping in predicting the dissolution profiles of solid oral dosage form. In this study, N = 36 batches of representative sinomenine hydrochloride sustained-release tablets were prepared, using a D-optimal design, to introduce adequate variability, and the Raman mapping data of each tablet were acquired. The partial least squares regression models were established using three kinds of different modes, named single point mode, average mode and multi-point mode, to predict the dissolution profiles based on Raman mapping data. The percent dissolutions at specific time points and the parameters of an exponential function, which was employed to fit the dissolution profiles, were predicted, and the accuracy and precision of prediction were tested. The results showed that the multi-point mode displayed the best accuracy and precision in the prediction of both the dissolutions at the specific time points and the function parameters. In summary, the established method based on Raman mapping avoids the shortcomings of traditional dissolution testing protocols, such as complex operation, time-consuming and high analysis cost, thus has great potential of application and popularization.

Evaluation of Clinical Effect of Double Dose Tamsulosin Hydrochloride Sustained-release Tablets on Type �� Prostatitis

Evaluation of Clinical Effect of Double Dose Tamsulosin Hydrochloride Sustained-release Tablets on Type �� Prostatitis

Clinical efficacy of tolperisone hydrochloride sustained release tablets in patients with acute or exacerbation of chronic musculoskeletal pain

<h3>ЦЕЛЬ ИССЛЕДОВАНИЯ</h3> Изучение клинической эффективности препарата толперизона гидрохлорида пролонгированного высвобождения 450 мг (прием один раз в сутки) у пациентов с острой болью или обострением хронической скелетно-мышечной боли. <h3>МАТЕРИАЛ И МЕТОДЫ</h3> В исследование включены 30 пациентов с острой болью или обострением хронической скелетно-мышечной боли, средний возраст 44,7±3,8 года. Исследование проводилось по зарегистрированному показанию к препарату мидокалм лонг — лечение болезненного мышечного спазма, связанного с заболеваниями скелетно-мышечной системы. Пациенты получали Мидокалм Лонг один раз в сутки после еды в течение 14 дней. Клиническое исследование проводили до назначения препарата и в динамике — через 7 и 14 дней, с использованием аналоговых шкал боли, опросника функциональных нарушений Роланда—Морриса, индекса мышечного синдрома для количественного выражения состояния скелетных мышц, опросника качества жизни EQ-5D-3L (русская версия) и оценки общего клинического впечатления для оценки эффективности лечения. <h3>РЕЗУЛЬТАТЫ</h3> Анальгезирующий эффект препарата мидокалм лонг статистически значимо проявлялся уже к 7-му дню лечения, при этом максимальный эффект терапии отмечен на 14-й день. Через 7 сут ограничение жизнедеятельности по опроснику функциональных нарушений Роланда—Морриса уменьшилось на 47%, а к 14-му дню снижение достигло 85%. Было установлено, что индекс мышечного синдрома (до лечения Me — 12) на 7-й день от начала лечения соответствовал 7, а к 14 дню — 2 (<i>p</i>&lt;0,001). Анализ данных EQ-5D-3L показал нарастание качества жизни пациента, что проявляется статистически значимой динамикой каждого из пяти показателей опросника. Оценка общего клинического впечатления об изменении состояния пациентов продемонстрировала положительную тенденцию, и к 14-му дню проводимой терапии препаратом мидокалм лонг у большинства пациентов наблюдался выраженный клинический эффект. <h3>ЗАКЛЮЧЕНИЕ</h3> Результаты исследования продемонстрировали клиническую эффективность толперизона гидрохлорида пролонгированного высвобождения 450 мг у пациентов с острой болью или обострением хронической скелетно-мышечной боли.

The effectiveness of tamsulosin hydrochloride with terazosin combination therapy for chronic prostatitis Type-III b.

Objectives:To study the therapeutic effects of combined tamsulosin hydrochloride and terazosin treatment for patients with chronic prostatitis Type-III b.Methods:This study involved 180 patients with chronic prostatitis Type-III b treated between January 2018 and December 2020 conducted at Nanhua Hospital Affiliated to Nanhua University. Patients were randomly divided into two equal groups: one receiving oral terazosin hydrochloride tablets only (control group), and one orally receiving both tamsulosin hydrochloride sustained-release tablets and terazosin hydrochloride tablets (observation group). Outcome measurements included symptom scoring, inflammatory cytokine levels, as well as white blood cell and lecithin body counts in the prostatic fluid.Results:After 30 days of treatment, the observation group showed greater treatment effectiveness (86.67% vs. 73.33%, P<0.05). QLS, USS, PS, and NIH-CPSI symptom scores were lower in the observation group than the control group (P<0.05). No differences in adverse event distribution and incidence were noted. EPS IL-2 increased more in the observation group, while PGE-2, MIP-1α, and MIP-2 decreased more in the observation group. WBC levels decreased more in the observation group, while lecithin body levels increased more in the observation group.Conclusion:The combination of tamsulosin hydrochloride and terazosin for the treatment of patients with chronic prostatitis Type-III b has a significant effect. This approach reduced patient symptoms, lowered inflammatory biomarkers, and generally improved quality of life. This approach appears to have clinical value worthy of future investigation.

A Comparison of the Clinical Effectiveness Between Low-Dose Strong Opioids and Non-Steroidal Anti-Inflammatory Drugs in the Treatment of Mild Cancer Pain: A Randomized Trial.

ObjectiveThe present study aims to explore the effectiveness and safety of low-dose strong opioids compared with non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of mild cancer pain.MethodsFrom September 2016 to September 2018, 66 patients with a malignant tumor and mild cancer pain admitted to the Department of Oncology of Dalian Fifth People’s Hospital were divided into the group A (treated with ibuprofen sustained-release tablets for pain relief) and the group B (treated with oxycodone hydrochloride sustained-release tablets for pain relief). After 7 days of treatment, the pain relief (Numeric Rating Scale [NRS]), physical strength, quality of life scores (Zubrod/ECOG/WHO [ZPS]), the Edmonton Symptom Assessment System [ESAS], and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core15-Palliative [EORTC QLQ-C15-PAL] scores), and the occurrence of adverse reactions between the two groups were compared. The occurrence of adverse reactions in the mid-term (after one month and three months of treatment) between the two groups were also compared.ResultsBoth groups had over 90% analgesic efficiency, but complete pain relief was more likely to be obtained in the group B (41.18%). The total analgesic efficiency in the group B was higher (100%) than in the group A (98.9%), and the difference was statistically significant (P < 0.05). The differences in the physical strength and quality of life scores in the two groups before and after treatment were statistically significant (P < 0.05). The differences in the ZPS scores between the two groups were statistically significant (P < 0.05). The differences in ESAS and EORTC QLQ-C15-PAL scores between groups were not statistically significant (P > 0.05).ConclusionThe application of low-dose oxycodone hydrochloride sustained-release tablets as the initial medication for patients with mild cancer pain was safe and effective, and the adverse reactions were easy to manage.

Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus

ObjectivesThis study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).MethodsThis randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.ResultsThere were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.ConclusionsMetformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.

Determination of 7 N-nitrosoamines in Metformin Hydrochloride Sustained Release Tablets by LC-HRMS

Determination of 7 N-nitrosoamines in Metformin Hydrochloride Sustained Release Tablets by LC-HRMS